Kornimate/medical-research-clean huggingface dataset:
a study of solifenacin with bladder training versus solifenacin alone in patients with overactive bladder (solar)

Conditions: Overactive Bladder; Urinary Incontinence; Urge Incontinence

Summary: this study will look at a drug for oab (solifenacin) in combination with a non drug treatment (bladder training) compared to the drug on its own. the study will compare the symptoms of oab by assessing patient diaries and other patient reported outcomes.

subjects are screened between day -14 and day -1. at day 0 subjects will enter a randomized, parallel group study. after fulfilling all selection criteria, subjects will be randomized to one of two treatment arms, solifenacin 5mg with bladder training or solifenacin 5mg alone. after 8 weeks of treatment subjects will be sub divided; subjects on solifenacin 5mg with bladder training will be given the option to increase dose and be divided into solifenacin 5mg with bladder training or solifenacin 10mg with bladder training. subjects on solifenacin alone, will also be given the option to increase dose and be divided into solifenacin 5mg alone and solifenacin 10mg alone. there are 5 visits in total: visit 1(screening), visit 2 (randomisation), visit 3 (week 4), visit 4 (week 8), telephone visit (week 12) and visit 5 (week 16) all subjects receive medication in the form of solifenacin succinate 5mg tablets (two tablets for 10mg) (company code: ym905, company serial number: rvg29151) subjects randomized to bladder training will receive a single sheet of instructions for bladder training.

Eligibility criteria:
inclusion criteria: * symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for\> 3 months exclusion criteria: * clinically significant outflow obstruction * significant post void residual volume * significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator. * patient with a neurological cause for abnormal detrusor activity. * evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs

Keywords: treatment outcomes overactive bladder solifenacin succinate urinary incontinence urge incontinence frequency
differential diagnosis athlete's heart from cardiomyopathy

Conditions: Athlete's Heart

Summary: assess the effects of strength sport to heart structure and function by t1 mapping with cardiac resonance imaging.


Eligibility criteria:
inclusion criteria: * same exercise exclusion criteria: * intolerance test
early occupational therapy for delirium prevention in older patients admitted to critical care unit

Conditions: Delirium; Alteration of Cognitive Function; Incompetence, Functional

Summary: this is a randomized, controlled trial to compare the efficacy of two strategies of non-pharmacological prevention of delirium in critically non-ventilated older patients: * standard non-pharmacological prevention * intensive nonpharmacological prevention (standard non-pharmacological prevention plus early and intensive occupational therapy).

delirium is a complication in older, with incidences 70-87% in ccu. this increases mortality, hospital stay, hospital cost, and cognitive impairment. occupational therapy (ot) improves independence at discharge, and reduction in delirium in patients undergoing mechanical ventilation. this study compares the efficacy of non pharmacological standard prevention (control group) versus intensive nonpharmacological prevention (experimental group) in the delirium duration in older admitted ccu.

Eligibility criteria:
inclusion criteria: * age over 60 years. * admission to ccu for monitoring by acute or chronic illness, expected more than 24 hours * informed consent of patient or family related. exclusion criteria: * cognitive impairment before to admission (measured by test reporter-tin). * severe disorder of communication and cultural constraint of language (inhability of properly communicating in spanish) * delirium at ccu admission or at the beginning of the intervention * need for mechanical ventilation * early limitation of therapeutic efforts and greater comorbidity with expected mortality within 90 days (in the opinion of the treating team).

Keywords: older delirium cognitive status occupational therapy critically ill patients
effect of american ginseng on exercise-induced muscle soreness

Conditions: Muscle Damage

Summary: healthy participants will ingest american ginseng daily or a placebo for four weeks prior to engaging in a unaccustomed exercise bout designed to induce mild-moderate muscle soreness. muscle soreness will be assessed via decrements in muscle strength and with a self-rating of perceived soreness before and several times after the exercise.

healthy men and women will consume either 2000 mg of american ginseng daily (four 500 mg pills will be taken at four different times during the day always with food/meals) or a placebo (4 cellulose) for four weeks prior to engaging in a 40 minute downhill treadmill jog (12% decline) at a speed of 7 miles per hour. participants will consume one pill with breakfast, one pill with lunch, one pill with dinner and another pill with a snack either between meals or prior to bedtime. the exercise will be consist of five, eight minute bouts of jogging with two minutes of rest/recovery in between. the degree of muscle soreness will be assessed using a biodex strength testing machine (isometric and concentric isokinetic torque), and a self-rating of perceived soreness on a scale from zero to ten. all of the above measures will be taken before and several times after the downhill jogging protocol.

Eligibility criteria:
inclusion criteria: * healthy men or women, (women must weigh between 55-65 kg., while men must weigh between 75-85kg). * participants must not have engaged in any endurance run training in the past 9 months. exclusion criteria: * injured * regular runners * pregnant (or with any chance they may become pregnant) * breast-feeding * diabetics or those taking medication for diabetes * insomniacs * schizophrenics * hyper- or hypotension * cancer * irregular heartbeats * heart disease * females with endometriosis or uterine fibroids * those who have surgery scheduled during the study or within the two weeks following the completion of the study * those taking warfarin or medication for depression.

Keywords: muscle soreness muscle function damage ginseng
collagenase in the treatment of adhesive capsulitis (frozen shoulder)

Conditions: Adhesive Capsulitis; Frozen Shoulder

Summary: the purpose of this study is to test collagenase injection therapy to dissolve adhesions causing frozen shoulder.

in a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to lyse the adhesions associated with the shoulder capsule in adhesive capsulitis (frozen shoulder). treatment success may obviate the need for extensive physical therapy and/or shoulder arthroscopy (surgery) to correct this condition and restore normal and pain free shoulder motion.

Eligibility criteria:
inclusion criteria: * diagnosis of frozen shoulder of at least one month duration exclusion criteria: * shoulder arthritis * rotator cuff tears * any chronic, serious, uncontrolled medical condition * inability to conform to study visits (20-30 per year)

Keywords: frozen shoulder
lexaptepid pegol (nox-h94) in esa-hyporesponsive anemia in dialysis patients

Conditions: Anemia; End Stage Renal Disease

Summary: dialysis patients regularly suffer from anemia which may be caused by various contributing factors, alone or in combination, including blood loss, low erythropoietin and iron sequestration. in most patients, the anemia is responsive to treatment with erythropoietin or other erythropoiesis stimulating agents (esa) alone or in combination with intravenous (i.v.) iron. in about 10% of patients however, the anaemia does not respond appropriately to this standard treatment and high to very high doses of esa and i.v. iron are used to maintain acceptable hemoglobin concentrations. in these patients, hepcidin was identified as a causative factor leading to anemia of chronic disease with functional iron deficiency and esa-hyporesponsiveness. the spiegelmer lexaptepid pegol (nox-h94) offers a hepcidin-specific approach to the treatment of anemia of chronic disease. the safety and the activity of lexaptepid pegol are supported by data from healthy subjects and patients with multiple myeloma or lymphoma. the present study in dialysis patients with functional iron deficiency and esa-hyporesponsiveness is conducted to demonstrate the safety of lexaptepid pegol in this population, to investigate its pharmacokinetic (pk) and pharmacodynamic (pd) profiles and its efficacy in increasing haemoglobin (hb) in dialysis patients.


Eligibility criteria:
inclusion criteria: * end stage renal disease treated with maintenance hemodialysis. * anemia : hb 7 to 11 g/dl. * functional iron deficiency: transferrin saturation \<30%, ferritin ≥300 ng/ml. * esa-hyporesponsiveness with erythropoietin dose ≥12,000 iu/ week. exclusion criteria: * treatment with darbepoetin or methoxy-polyethyleneglycol-epoetin. * uncontrolled / unstable cardiovascular , peripheral arterial or cerebrovascular disease. * congestive heart failure: new york heart association class iii or iv. * unstable angina, myocardial infarction, percutaneous transluminal coronary angioplasty/stents, or coronary artery bypass grafting \<3 months prior screening. * any other medical conditions requiring a change in treatment within 4 weeks prior to screening or making study participation unadvisable. * history of clinically relevant hemolysis and/or blood loss. * ast, alt, or bilirubin ≥2.0 times the upper limit of normal. * known bone marrow fibrosis. * treatment with i.v. iron \<4 weeks prior to screening or during the screening period or change in erythropoietin dose during last month. * any acute or chronic infection, viral or bacterial within 4 weeks prior to screening or during the screening period considered as systemic infection.

Keywords: dialysis
the protrieve protector study

Conditions: Venous Thromboembolism; Deep Venous Thrombosis

Summary: the protrieve protector study is a prospective, single-arm, multicenter study of the protrieve sheath.

the primary study objective is to evaluate the safety and effectiveness of the protrieve sheath in preventing clinically significant intraprocedural pulmonary embolism by providing embolic protection in the ivc during thrombectomy procedures to treat dvt.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. planned intervention for dvt presenting with one or more of the following characteristics indicative of elevated risk for pe: 1. bilateral iliofemoral dvt 2. clot extending into or located in the ivc 3. in-stent thrombosis 4. presence of thrombosed ivc filter 5. other features that the investigator deems put the subject at elevated risk for thromboembolism 3. willing and able to provide informed consent exclusion criteria: 1. current symptomatic pe 2. known anatomic inability to place protrieve device via jugular vein access site 3. presence of clot extending to the ivc-right atrial junction or in the svc 4. subject is pregnant 5. severe allergy to iodinated contrast agents that cannot be mitigated 6. inr \> 1.7 if not currently on anticoagulation therapy, platelets \< 50,000/μl which cannot be corrected prior to enrollment, or hemoglobin \< 8.0 g/dl 7. severe renal impairment in patients who are not yet on dialysis that in the investigator's discretion would pose risk to the patient with the use of marketed contrast agents 8. subject is participating in another study that may interfere with this study 9. subject has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the subject 10. subject has previously completed or withdrawn from this study 11. limb-threatening circulatory compromise (e.g., phlegmasia) 12. uncontrolled severe hypertension on repeated readings (systolic \> 180mmhg or diastolic \> 105mmhg) 13. severe allergy, hypersensitivity to, or thrombocytopenia from heparin 14. inability to provide therapeutic anticoagulation per investigator discretion 15. known hypercoagulable states that, in the opinion of the investigator, cannot be medically managed throughout the study period 16. inability to be a candidate for intervention due to medical or technical reasons based on physician judgement

Keywords: venous thromboembolism deep venous thrombosis percutaneous mechanical thrombectomy
the beach interview study- pregnant and breastfeeding mothers

Conditions: Pediatric Obesity; Recruitment

Summary: interview pregnant and breastfeeding mothers in the gainesville, fl area to optimize; clinical study recruitment and retention, patient-centered outcomes, and stool collection procedures.

this is an interview study that will enroll mothers during 28 weeks or greater of pregnancy and assess recruitment, patient-centered outcomes, and stool collection procedures via individualized interviews and data collection. participants will be recruited from the greater gainesville, fl area. data collection will include questionnaires/surveys as well as minimal risk non-invasive biological samples such as stool, human milk, saliva, vaginal swab, and urine collection. participants will be seen at a location convenient for them.

Eligibility criteria:
inclusion criteria: * females 18\>45, between 28-38 weeks pregnant, lives in gainesville, florida, and committed to exclusively breastfeeding through 6 months. * females 18\>45, actively breastfeeding for \<12 months and lives in gainesville, florida exclusion criteria: * mothers who do not plan to exclusively breastfeed their infant for at least the first 6 months or actively breastfeeding. * mothers who do not live in gainesville, fl * mothers who are not between the ages of 18-45 * mothers who are not between 28-38 weeks of gestation or a breastfeeding mother. * mothers who have only one breast which is capable of producing milk and/or have a history of inadequate milk production. * mothers who have consumed alcohol during this pregnancy. * mothers who have abused drugs during this pregnancy. * mothers who have smoked during this pregnancy. * mothers who have been diagnosed with pre-eclampsia during this pregnancy. * mothers who have had a previous pre-term delivery (baby born 2 months before the due date or \<35 weeks).

Keywords: retention lactation human milk pregnancy clinical research studies beach
the interaction between intestinal microbiota, innate defense and epithelial integrity in the development of pouchitis

Conditions: Pouchitis

Summary: pouchitis is a common complication following proctocolectomy with ileal pouch anal anastomosis (ipaa) in patients with ulcerative colitis (uc). it affects the quality of life and can become a chronic problem. the aetiology of pouchitis is not completely understood. a crucial role of the intestinal microbiota has been suggested, but no causative agent has been identified so far. furthermore, the defensin expression and the epithelial integrity are altered in inflammatory bowel diseases and may play an important role in the development of intestinal inflammation. therefore, it has been hypothesized that the interaction between an altered microbiota composition, a defective epithelial integrity and changes in innate defense parameters such as defensins has a pivotal role in the development of pouchitis in uc patients.


Eligibility criteria:
inclusion criteria: * patients with ulcerative colitis undergoing a total colectomy with ipaa for steroid dependent disease, therapy-refractory disease, colorectal cancer or severe dysplasia * 18-65 years of age exclusion criteria: * unable to give informed consent * pregnant or breastfeeding

Keywords: pouch pouchitis ulcerative colitis microbiota defensins epithelial integrity
assessment of clinical & radiographic efficiency of manual & pediatric rotary systems in primary root canal preparation

Conditions: Manual; Rotation; Obturation; Post Operative Pain

Summary: manual files used for the pulpectomy of primary teeth have some disadvantages such as time wastage and the occurrence of iatrogenic errors compared to rotary systems. little studies have been done to clinically evaluate the kedo-s square \& fanta af™ baby rotary systems in relation to the quality of obturation, instrumentation time and postoperative pain in root canal preparation of primary molars using cbct.

biomechanical preparation is one of the most important steps of primary teeth pulpectomy, which are primarily targeted during canal debridement . conventionally, hand files were used for cleaning and shaping in primary teeth with some disadvantages such as time wastage and the occurrence of iatrogenic errors such as zipping, lateral perforations, apical obstruction, and canal transportation. the use of rotary instruments for primary tooth instrumentation is faster, affordable, and yields consistent, reliable results. numerous rotary endodontic systems designed primarily for application in permanent teeth, have been suggested for primary teeth root canal preparation. since the primary teeth have a ribbon-shaped anatomy and shorter, thinner curved roots than permanent teeth, the use of these files in pulpectomy of primary teeth could produce lateral perforations. as a result, there was a great need for the development of a unique pediatric rotary file system. the kedo-s square rotary system is a single file system specifically designed for paediatric use. it consists of two files, one for anterior primary teeth (a1) and one for posterior primary teeth (p1) also, fanta af™-baby rotary system, another specifically generated paediatric rotary file, was produced using ni-ti controlled memory (cm)-wire technology. a good root canal treatment in primary teeth is dependent on the quality of biomechanical preparation, the type of obturating material used with as few voids as possible, and the achievement of a good hermetic seal. also, treatment time is an important aspect as reduced chairside time increases children's cooperation for dental treatment, reduces anxiety, and making the treatment protocol optimal. another factor affecting the success of primary teeth pulpectomy is the postoperative pain which may be due to extrusion of foreign particles into peri-radicular tissues accordingly, causing inflammation and releasing inflammatory mediators.

Eligibility criteria:
inclusion criteria: * healthy cooperative children * non-vital posterior teeth with sufficient coronal structure * intact 2/3rd root structure * no mobility or external pathological root resorption exclusion criteria: * uncooperative children * children with systemic illness * non-restorable primary molars * primary molars with sever mobility, or pathological root resorption

Keywords: cone-beam computed tomography kedo-s square fanta af™ baby
real-world effectiveness and safety of trastuzumab deruxtecan in patients with locally advanced or metastatic her2-positive gastric or gastroesophageal junction adenocarcinoma in china

Conditions: HER2-positive Gastric Cancer; HER2-positive Gastroesophageal Junction

Summary: trastuzumab deruxtecan's (t-dxd's) efficacy and safety has been confirmed in traditional clinical trials, there is a lack of real-world evidence, especially among chinese patients. the objective of this study is to evaluate real-world effectiveness and safety profile of t-dxd by collecting real-world data treating in patients with locally advanced or metastatic her2-positive gastric or gastroesophageal junction adenocarcinoma.

the primary objective of this study is to evaluate the effectiveness of t-dxd in real-world setting (real-word time to treatment failure). the secondary objectives of this study are to assess the safety profile of t-dxd (treatment related adverse events \[trae\] regardless of grade, and physician reported adverse events of special interest \[aesi\] regardless of grade, etc.) and to evaluate effectiveness of t-dxd (real-world time to next treatment). this is an non-interventional, observational study. no drug will be provided or administered as part of this protocol; however, participants on t-dxd will be enrolled in this study.

Eligibility criteria:
participants must meet all the following inclusion criteria to be eligible for the study: 1. participants with pathologically diagnosed locally advanced unresectable or metastatic gastric cancer/gastroesophageal junction adenocarcinoma (gc/geja). 2. ≥18 years of age at the time of starting the first dose of t-dxd and signing informed consent form (icf), capable of providing informed consent. 3. her2-positive status (ihc 3+ or ihc 2+/ish +). 4. received prior anti-cancer treatment regimens according to national medical products administration indication or clinical judgement of physician. 5. decision to newly initiate t-dxd before study icf signing. if the participants have started the first dose of t-dxd no longer than 21 days before enrollment, they could be enrolled if the signed and dated icf could be obtained. exclusion criteria： participants who meet any of the following criteria will be excluded from the study: 1. pregnancy or breastfeeding. 2. participants who at the time of data collection of the study are participating in or have participated in an interventional study that remains blinded. 3. known hypersensitivity to either the drug substances or inactive ingredients in the drug product. 4. judged by the investigator to be unfit to participate in the study.

Keywords: her2-positive gastric cancer her2-positive gastroesophageal junction
combined colon and endometrial cancer screening in women with hnpcc

Conditions: Colon Cancer

Summary: primary objectives: to test the feasibility of combined colon and endometrial cancer screening in women with increased risk for colon and endometrial cancer. to measure patient satisfaction for the combined procedure.

women with certain medical conditions have an increased risk for colon and endometrial cancer. currently, women go through separate screening procedures. endometrial biopsies are performed at a separate visit to the gynecologist, and patients are not sedated for the procedure. this study will involve performing an endometrial biopsy while you are sedated for your colonoscopy. women who are able to have children must have a negative blood or urine pregnancy test before they can take part in this study. as part of the study, you will be asked about your past experience with endometrial biopsy and colonoscopy. you will be asked about your perception of pain, your expectations, and the benefits and barriers to the combined screening. you will then be sedated. the colonoscopy will be performed first by a gastroenterologist. this will be followed by the endometrial biopsy, which will be performed by a gynecologic oncologist. a telephone interview will be performed two weeks after this procedure. the interview will last about 15 minutes. you will be asked about your perception of pain and the benefits and barriers to the combined screening. this is an investigational study. a total of 50 women will take part in this study. all will be enrolled at m. d. anderson.

Eligibility criteria:
inclusion criteria: 1) women with medical indications for colonoscopy and endometrial biopsy. exclusion criteria: 1) must be 18 years of age and older.

Keywords: hereditary non-polyposis colon cancer colon cancer endometrial cancer cancer screening interview hnpcc